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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Impedance Measuring Device Utilizing Oscillation Techniques
510(k) Number K191876
Device Name PulmoScan
Applicant
Cognita Labs, LLC
700 N Main St. Suite C1
Santa Ana,  CA  92701
Applicant Contact Rajoshi Biswas
Correspondent
Cognita Labs, LLC
700 N Main St. Suite C1
Santa Ana,  CA  92701
Correspondent Contact Rajoshi Biswas
Regulation Number868.1840
Classification Product Code
PNV  
Date Received07/15/2019
Decision Date 03/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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